Reusable blood lines

ABSTRACT

Blood lines for hemodialysis and other blood handling procedures may be reused by placing connectors intermediately along the length of the blood lines so that the lines can be disconnected to separate out reusable portions thereof. Specifically, the bulk of the blood lines used may comprise branchless lengths of tubing which are easily reusable, and may be cleaned and stored along with a dialyzer or similar device by connection to a conventional reuse machine. Also, the connectors on the blood lines which are reused may have first and second sealing surfaces. The first sealing surfaces are used in the connections made to form the blood line in its normal form for use. Then, during cleaning and sterilization for reuse, the reusable connectors can connect first and second lengths of blood lines together making use of a second sealing surface, in which the first sealing surfaces are exposed to cleaning/storing solution to cause cleaning and antibacterial action on the first sealing surfaces.

BACKGROUND OF THE INVENTION

In the field of blood treatment, hemodialysis is the most widely usedtechnique, although other techniques are also available such asplasmapheresis, hemoperfusion, blood oxygenation, and techniques forpassing blood through blood treatment media such as an absorptive agentfor the removal of toxins or the like. Typically, an arterial blood setdelivers blood from the patient to the hemodialyzer or other desiredblood treatment unit. After the blood has passed through thehemodialyzer, it is conveyed through a venous blood set back to thepatient.

The arterial and venous blood sets typically each have about two metersof tubing, extending from patient connectors to other set componentssuch as bubble removal chambers, a length of roller pump tubing oranother pump device fitment, branch connection sites, a pressure pillow,and the like. Also, typically another meter of tubing extends betweenthese various other set components and the dialyzer or other bloodtreatment device. Numerous other known devices may also be positioned onthe blood sets, such as filters.

In the early days of dialysis, blood lines and dialyzers werehand-assembled before dialysis, and then disassembled, piece-by-piece,after dialysis for cleaning and resterilization. These early dialyzerswere of the plate dialyzer form, and, generally, everything was reusedexcept for the dialyzing membranes. Typically, glass chambers andvarious metallic fittings were press fit into latex blood tubing, withthese components being reused a large number of times.

Since such a process was very expensive in terms of labor cost and timeconsumption, plastic, pre-sterilized dialyzers and blood lines wereintroduced in the late 1960's. Initially, these items were disposed ofafter a single use. However, in due course, the dialyzers particularlybegan to be reused, always on the same patient and typically for onlyfour to six uses. In countries with less government funding and/or lowercost of labor the reuse of dialyzers, bloodlines, and even fistulaneedles has been and still is common, despite safety issues.

When U.S. government funding of dialysis began in the mid 1970's,dialyzer reuse substantially disappeared. However, since another fundingchange in 1982, U.S. dialyzer reuse has been once again increasing.

Particularly, hollow fiber dialyzers have been reused, especially sincethe introduction of non-cellulosic membranes such as polysulphone, whichare more capable of exposure to oxidizing agents such as moreconcentrated liquid bleach, so that at the present time mosthemodialyzers are reused, with the reuse typically being done withsemi-automated equipment that controls the rinsing, bleach andantiseptic solution application, and other aspects of the disinfectionprocess. Typically, in the more recent reuse techniques, the dialyzer isfirst disconnected from the arterial and venous blood sets, which arethrown away. Hollow fiber dialyzers have their headers removed in somecases so that the fiber manifolds can be swabbed and cleaned. Then, thedialyzers are connected by short reuse tubes which join its blood inlet,outlet, and dialysate ports to the respective ports on the reuseequipment. The blood and dialysate pathways are sequentially rinsed,followed by application of a bleach solution and another water rinse,following which the dialyzer is filled with a disinfectant solution. Thedialyzer is then separated from the short reuse connecting tubes capped,and then stored until the patient's next dialysis. Dialyses aretypically performed on a patient three times a week.

Immediately prior to the next use, the dialyzer is typically connectedto a new arterial set that has been previously primed with sterile,physiological saline. Then a venous set is attached. The system isrinsed with sterile physiologic saline solution for essentialelimination of the disinfectant.

Commonly, blood lines of the arterial and venous sets have not beenreused, partly because the cost of blood lines is less than the cost ofdialyzers, and also because blood lines are more difficult to reuse thandialyzers. This is because, contrary to the typical hollow fiberdialyzers, traditional blood lines have numerous branch lines, dead endspaces, and enlarged spaces such as are found in the bubble removalchambers and pressure pillows. Thus, efficient, effective cleaning oftraditional arterial and venous sets is difficult or impossible.

Also, conventional arterial and venous sets are more difficult to set upfor dialysis reuse than typical hollow fiber dialyzers, since the abovementioned components also cause difficulties in the removal of thechemical sterilant prior to reuse. The presence of filters, as arecommonly found in the venous sets, presents a major obstacle toeffective cleaning prior to reuse. Likewise, arterial and venous setstend to be long and cumbersome after they have been unwound, making itdifficult to manipulate the set during reuse, storage, and setup.

Additionally, unlike dialyzers, certain components of the prior artblood lines are subjected to repeated mechanical force which, as theyare made from materials which degrade with use, and thus are not idealfor reuse. This also raises safety issues. For example, the roller pumptubing segment typically carried by blood sets can quickly suffer from adeterioration in elasticity, since the pump segment tubing is crushedand reexpanded thousands of times by the action of the roller pump. Thefunctioning of the pump segment tubing depends upon its elastic "springback" capability. With a loss of some of that characteristic to springback from the crushing provided by the roller pump, the amount of bloodpumped per rotation of the roller pump rotor decreases. To make mattersworse, this can go unnoticed as blood flow rates are typicallycalculated indirectly in the blood pump by a measurement of therotational speed of the pump rotor, so that the flow rate may decreaseeven though the pump rotor speed is maintained. This can take place inpart because plasticizers of the typically PVC roller pump segment mayhave leached out or otherwise because of characteristics of thematerials used.

Also, a worn pump segment or diaphragm may shed into the pumped bloodexcessive amounts of particles from the plastic of which the segment ismade.

Also, blood filters and transducer protector filters are reused onlywith difficulty and inefficiency, because the blood tends to clog theopenings of the respective filters. Likewise injection sites may quicklywear out due to repeated punctures and the loss of elasticity as aconsequence of use in a dialysis procedure. Organic material thatcollects in the puncture sites of elastomeric injection site partitionsis especially difficult to remove and decontaminate.

Currently, arterial and venous sets for dialysis are reused in someclinics. However, in such reused sets the arterial blood line isgenerally not equipped with an arterial chamber, which prevents accuratemonitoring of arterial pre-pump or post-pump pressures, raising asignificant safety issue. Likewise, venous blood lines that are reusedgenerally do not include a filter, which raises another significantsafety issue. Furthermore, the reusable arterial and venous blood linesgenerally lack injection sites and other branch lines, which creates asignificant inconvenience and a safety issue.

The reason for these deficiencies in the above reusable blood lines liesin the difficulty of reusing blood lines which have chambers, filters,injection sites, dead end side ports, and branch lines.

Luther et al. U.S. Pat. No. 4,612,170 discloses a blood oxygenator whichhas a removable and reusable heat exchanger. The remainder of theoxygenator and the blood lines are apparently not intended not to bereused.

Also, the Medisystems Corporation offered for sale during the 1970's and1980's a neonatal venous line for dialysis in which a central chamberwith filter was removably connected at both ends to lengths of tubingwhich each carried a branching connector site. The purpose of this wasto permit replacement of the filter in case the filter became severelyclotted during dialysis, to which neonatal dialysis is sometimes prone.It is not believed that any suggestion was made about reuse of any ofthe components of the neonatal venous line.

DESCRIPTION OF THE INVENTION

By this invention, a blood treatment method is provided, which istypically a hemodialysis technique but may comprise other bloodtreatment methods as well. The method comprises the following steps:

One flows blood sequentially through connected members which comprise afirst conduit; a first blood handling member comprising at least one ofa first debubbling chamber and a pump device fitment; a second conduit;a blood treatment device such as a membrane dialyzer; a third conduit; asecond blood handling member comprising at least one of a seconddebubbling chamber and pump device fitment; and a fourth conduit. In apreferred embodiment, the blood treatment device is a hemodialyzer.Typically, blood is withdrawn from the patient into the first conduit,and returned to the patient through the fourth conduit. The conduits aretypically flexible plastic tubes of the arterial and venous blood sets,although rigid materials and/or non-tubular shaped conduits canpreferably be employed in certain circumstance such as cassetted devicesor conduits that are permanent or semi-permanent attachments to thetreatment device or monitoring/supply device.

Following such treatment, one terminates the flowing of blood andsubstantially removes the blood from the above components.

In accordance with this invention, at least one of the first and secondblood handling members is disconnected from the respective flexibletubes and removed. One then connects ends of at least one of the firstand second conduits and/or the third and fourth conduits together, torecreate a blood flow path with the absence of at least one the firstand second blood handling members. At least one of the first and fourthconduits are then connected at a free end to a source ofcleaning/storage solution, which may sequentially or otherwise includewater for rinsing, bleach, and a disinfecting solution used for storageof the blood lines, either with the blood lines being connected to theblood treatment device (hemodialyzer) or separate therefrom if desired.One then flows the cleaning/storage solution through the first throughfourth conduits and, optionally, the blood treatment device which inthat circumstance is not disconnected from the tubes.

Prior to such connection, the ends of the first, second, third andfourth conduits are preferably treated with an antimicrobial agent suchas liquid bleach, following which, the first and second, and the thirdand fourth, conduits may be connected, thus reducing the risk ofmicrobial contamination.

It is preferred that the above blood treatment method is performed aplurality of times, for example a dozen or more times, with at leastsome of the same first through fourth conduits . This can save 65percent or more of conventional, fully disposable plastic of the bloodline sets (by weight) in each dialysis procedure, since the firstthrough the fourth conduits may comprise the longest portions of therespective arterial and venous sets. Such a reuse, if universally usedin all current United States dialysis procedures, could reduce theconsumption of plastic up to four million kilograms per year, which mustnow be both paid for and then disposed of as biologically hazardousmaterial.

It should also be added that, particularly in the situation where theblood lines remain connected to the dialyzer during cleaning and storagefor reuse, the reuse of the first through fourth conduits can beaccomplished at an extremely low increased cost compared to the reuse ofthe membrane dialyzer by itself. The reuse cycle with a conventionalreuse machine can be practically the same whether the dialyzer isconnected to the reuse equipment alone, or with attached long tubeassemblies comprising the first through fourth conduits. Preferably,these long conduit assemblies are free of branch lines, dead end spacesassociated with branch lines and other components, and other featuresthat inhibit their reuse.

If desired, either or both of the second and third conduits may bepermanently connected to the dialyzer.

Also, the performance standards of the first through fourth conduits onreuse can remain high through a dozen reuses or more, providingperformance that is substantially equivalent to the original equipmentspecifications. It is generally preferred, to enhance reuse capability,that the first, second, third, and fourth (first through fourth)conduits are tubes made of a plastic which is substantially free ofplasticizers, or at least leachable plasticizers. For example,polyurethane, silicone, polycarbonate and similar materials may be used.Also, thermoplastic elastomer materials may be used such as Kraton, soldby The Shell Chemical Company.

Typically, with each reuse of the first through fourth conduits, newfirst and second blood handling members may be respectively connectedbetween the first and second, and the third and fourth, conduits.Priming solution may be passed through the connected conduits bloodhandling members, and blood treatment device (dialyzer), followed byflowing blood sequentially therethrough in accordance with the originalmethod described above.

Further in accordance with this invention, an arterial or venous set forblood handling is provided, usable in the above method. The setcomprises of a first typically flexible tube having ends whichrespectively carry a first connector (typically a dialyzer connector)and a second connector. A central assembly comprises a pathway conduithaving at least one of a blood degassing chamber, a connected branchtube, a pump device fitment, and an injection site. The central assemblycarries a third connector which is connected with the second connector,and a fourth connector.

A second typically flexible tube is also provided to the set, havingends which respectively carry a fifth connector and a sixth connector(typically a patient access connector). The fifth connector is connectedto the fourth connector of the central assembly. At least the second andfifth connectors are of the type which permit repeated connection anddisconnection to permit repeated, sealed blood flow through the setwhile the connectors are connected, so that they may be reused timeafter time, while the central assembly may be replaced.

The first flexible tube may correspond exactly to the previouslydiscussed second or third conduits. The second flexible tube maycorrespond exactly to the first or fourth conduits, depending on usage.

Also, it is preferred for at least the second connector and the fifthconnector to define first sealing surfaces that respectively sealinglyabut against other sealing surfaces of the third and fourth connectors,to which they are respectively connected. The second and fifthconnectors also have second sealing surfaces, the latter two connectorsbeing also connectable with each other to form a sealed connection bycontact of the second sealing surfaces while the first sealing surfacesare positioned in exposed manner within the connected second and fifthconnectors. This latter condition is accomplished after the centralassembly has been removed, and the first and second tubes are connectedtogether for cleaning and reuse. The second sealing surfaces form asealed connection between the second and fifth connectors by sealingcontact together, while the first sealing surfaces in this condition arepositioned in exposed manner within the connected second and fifthconnectors, so that antimicrobial solution in the joined first andsecond flexible tubes can be in contact with the first sealing surfaces.Thus, upon desired reuse of the first and second tubes, they may beconnected again with the third and fourth connectors of a new centralassembly under aseptic conditions since the first sealing surfaces havebeen cleaned and rendered aseptic.

The second and fifth connectors may each define a threaded sleeve ofdiffering diameter compared with the other sleeve, to permittelescoping, threaded interengagement for a locking connection while thesecond sealing surfaces are in sealing abutment.

Also, the threaded sleeve of at least one of the second and fifthconnectors may be threaded both inside and out to provide engagementbetween the second and fifth connectors, and also to alternativelyprovide engagement with the connectors of the central assembly.

Alternatively, an O-ring connector system may be used in which at leastone O-ring comprises at least one first or second sealing surface.

Further in accordance with this invention, a flow through bloodtreatment device and a connected blood set portion comprises a housing,a blood inlet, a blood outlet, and at least one membrane in the housing.The housing defines a blood flow path between the blood inlet and outleton one side of the membrane, and a second flow path defined on the otherside of the membrane. The blood inlet and the blood outlet are eachrespectively connected to lengths of first blood flow tubing by firstconnectors positioned at one end of each of the respective lengths offirst blood flow tubing, which connectors may provide permanentconnection if desired.

The first blood flow tubing carries on its other end a second connectorwhich is connected to a fifth connector (similar to that previouslydescribed) carried on one end of a second blood tube. Each length of thesecond blood tube is connected to a sixth connector, typically a patientaccess connector, on its end opposed to the end which carries the fifthconnector. Thus, a blood treatment device such as a dialyzer may beconnected to one or both of the arterial and venous blood sets, in whicheach of the inlet and outlet tubing assemblies comprises first andsecond lengths of tubing which are removable one from the other bydisengagement of the respective connectors.

Such an arrangement may be cleaned and stored for reuse. Then, whenreuse is desired, the respective lengths of first and second tubings canbe disconnected, a central assembly containing, for example one or moreblood degassing chambers and/or a blood pumping device such as rollerpump tubing, may be connected between the respective first and secondtubes so that the blood treatment device becomes ready for use.

The respective arterial and venous sixth connectors on the free ends ofthe second tubes may be connected to each other so that the flow path ofthe blood treatment device is formed into a closed loop, for storagepurposes. Alternatively, the respective sixth connectors may beconnected to opposed ends of a short shunt tube or an overconnector forthe same purpose.

Particularly, the second and fifth connectors of the above device mayhave the design previously described, where the connectors define firstand second sealing surfaces and where the second and fifth connectorsare connectable with each other, with abutment together of the secondsealing surfaces while the first sealing surfaces are positioned inexposed manner within the connectors, so that the first sealing surfacesmay be cleaned and rendered aseptic for subsequent sealing contact witha sealing surface of another connector.

Because the long first through fourth tubes may be reused many times,they may be made of larger inner cross-sectional area at a very smallcost increase, especially when factored over the many separate dialysesin which they are used. Larger inner cross-sectional areas, for exampleabout 0.17 to 0.4 cm², can desirably reduce the flow pressure drop,which is particularly of advantage in the higher flows of moderndialysis procedures.

Preferably, new first and second blood handling members may beincorporated into the blood treatment device which is to be reused afterthe antimicrobial agent has been completely removed from the system andreplaced with normal saline solution. Thus, setup can be fast andefficient, because the greater part of the blood sets are alreadyprimed.

DESCRIPTION OF DRAWINGS

FIG. 1 is plan view of a connected dialyzer, arterial blood set, andvenous blood set in accordance with this invention;

FIG. 2 is a generally schematic elevational view showing the dialyzerand blood sets of FIG. 1 connected to a reuse machine for cleansing ofthe system for later reuse, with certain set components removed;

FIGS. 3 and 4 are enlarged, detailed longitudinal sectional viewsillustrating embodiments of joined connectors as used in FIG. 1;

FIG. 5 is an enlarged longitudinal sectional view illustrating two ofthe connectors of FIGS. 3 and 4 joined together as shown in FIG. 2;

FIG. 6 is an enlarged, exploded longitudinal sectional view showinganother embodiment of connectors as they may be joined together in themanner of FIG. 3;

FIG. 7 is an enlarged, longitudinal sectional view showing anotherembodiment of connectors which are joined together for use in theconfiguration of FIG. 2;

FIG. 8a is an enlarged, exploded longitudinal sectional view, showinganother connector embodiment in the configuration of FIG. 1;

FIG. 8b is an enlarged longitudinal sectional view showing twoconnectors of FIG. 8a in the configuration of FIG. 2;

FIG. 8c is a longitudinal sectional view of an overconnector used inFIG. 8b;

FIG. 8d is a perspective view, with portions broken away, of anotherembodiment of overconnector for use similar to the overconnector of FIG.8c;

FIG. 9 is a longitudinal sectional view of another embodiment of joinedconnectors as shown in FIG. 2;

FIG. 10 is a sectional view of the connection of the patient connectorsto the reuse machine as shown in FIG. 2; and

FIG. 11 is a plan view of another embodiment of a dialyzer connected toa combined arterial-venous blood set in another embodiment of thisinvention.

DESCRIPTION OF SPECIFIC EMBODIMENTS

Referring to FIG. 1, the blood flow portions of a hemodialysis systemare shown. A conventional hemodialyzer 10 has a blood inlet 12 which isconnected by a conventional luer lock system to first connector 20 at anend of arterial blood set 14. Dialyzer 10 also has a blood outlet 16,which is connected to a first connector 52 of venous set 18. These sets14, 18 and dialyzer 10 are of conventional design except as otherwiseindicated herein in accordance with this invention.

First connector 20 is carried by first branchless, flexible tube 22 ofarterial set 14, which first tube terminates in second connector 24.Second connector 24 communicates with a third connector 26, which iscarried by central assembly 28 of arterial set 14. While first flexibletube 22 is preferably without branches or other components except forapproximately 100 cm. of plastic tubing, (preferably having an innerdiameter of 4.5 to 7 mm. or a lumen cross-sectional area of 0.17 to 0.38cm²) central assembly 28 may comprise a substantial number of branchingand other components carried with tubing segments 29, 30 and 31. Alength of roller pump tubing 32 is provided, shown to be in a rollerpump track 33 and being retained in line by a pair of pump tubingconnectors 34, 36, designed to accommodate the differing diameters ofthe respective lines. Connector 34 may have a branch connecting line 38which comprises an anti-backup heparin line, as an optional feature.Between tubings 30, 31 a debubbling chamber 40 may be provided havingconventional branch or side arm lines, one of such lines carrying atransducer protector 42 for conventional pressure measurements. At line31, another conventional branch line 44 may be provided for connectionwith a source of physiological saline solution. Other designs of centralassembly 28 may also be used.

Central assembly 28 terminates in a fourth connector 46, whichcommunicates with fifth connector 48 of a second length of flexibletubing 50, comprising a single, unbranched tubing length of about 180cm. length, and having a lumen cross section typically similar to firstflexible tube 22.

Finally, arterial set 14 may be terminated with a conventional sixthconnector 53 of luer lock type.

If desired, components may be added or subtracted to the arterial andvenous sets shown. For example, an injection site 54 of conventionaldesign may be placed on the arterial set in the position shown, or anyother desirable position, including on reusable tubing conduits 14, 50,72, or 18.

A significant difference in the arterial set 14 of this invention overthe prior art arterial sets lies in the presence and design ofconnectors 24, 26, and 46, 48. Arterial set 14 may be used in aconventional dialysis procedure. Then, at the end of the procedure,after the blood has been substantially rinsed from set 14, connectors 24and 26, and connectors 46, 48 may be respectively disconnected, andcentral assembly 28 may be removed. Then, connectors 24 and 48 may beconnected together in the manner to be shown below. Preferably, the modeof connection between connectors 24 and 48 is different from the mode ofconnection between connectors 24, 26 and 46, 48, so that the firstsealing surfaces utilized in sealing contact between the respectiveconnectors 24, 26 and 46, 48 are open and exposed within the connectedconnectors 24, 28, so that the application of cleaning/storage solutionthrough the set causes cleaning and antibacterial action on these firstsealing surfaces.

Venous blood set 18 also comprises a first connector 52, which connectsto or is integral with the blood outlet of dialyzer 10, and is carriedby a first length of tubing 56, which may be about 80 cm long and ispreferably free of branches in a manner similar to the previouslydescribed first tubing 22.

First tubing 56 terminates at its other end to second connector 58which, in turn, communicates with a third connector 60 carried by thecentral assembly 62 of this blood set 18. Central assembly 62 comprisesa filter-carrying debubbling chamber 64 and preferably branch lines asdesired, one of said branch lines carrying a transducer protector 66 ina manner similar to the previous arterial set 14.

Central assembly 62 also carries a fourth connector 68 which is insealed, connected relation to a fifth connector 70 which is carried uponsecond length of tubing 72. Second length of tubing 72 is similar inlength and diameter to the other second tubing 50, being also preferablyfree of branch connections, pressure pillows, injection sites, and otherchambers. On-off clamps 74 are preferably externally carried on thetubings adjacent the respective connectors, and are not deemed anintegral feature thereof.

Second tubing 72 of the venous set 18 terminates in a conventional sixthconnector 76 of the luer lock type, for patient access connection.

Here also, at the termination of dialysis and the removal of allpossible blood from the system, connectors 58, 60 and 68 and 70 may bedisconnected, and the preferably specially designed connectors 58, 70may be connected to each other, preferably in a manner as describedabove where the original sealing surfaces providing the sealedconnection between connectors 58, 60 and 68, 70 are exposed to theconnectors' interior for washing and contact with the cleaning/storagesolution in preparation for reuse.

Thus, first and second tubings 22, 50, 56, 72, comprising in thisembodiment about eighteen feet of tubing, can be reused in an indefinitenumber of dialysis procedures, resulting in substantial savings ofplastic and reduced problems of the disposal of biohazard waste. Witheach use, it is typically contemplated that new central assemblies 28,62 are connected into the respective sets between the respective firstand second tubes 22, 50, 56, 72, but if necessary and as possible,central assemblies 28, 62 may be cleaned and rehabilitated for reusealso.

FIG. 2 shows the set of this invention after disconnection of thecentral assemblies 28, 62, and reconnection of the respective long tubes22, 50, 56, 72, with the dialyzer 10, and the connected long tubes anddialyzer being mounted on a conventional reuse machine 80. Sixth patientconnectors 53, 76 of each set may be connected to special reuseconnectors 82, 84 which hold connectors 53, 76 in sealed relation toprovide cleaning/storage solution to the system with their first sealingsurfaces exposed to the solution so that the surfaces are cleaned. As isconventional, short tubes 88 from reuse machine 80 connect to thedialysis ports 90 of dialyzer 10, so that cleaning/storage solution,typically a sequence of various types of washing, sterilizing andstorage solutions, are applied to the dialyzer and the tubular setcomponents.

If desired, after such washing, connectors 53, 76, may be connectedtogether using an interconnector or an overconnector; the dialysis ports90 may be closed; and the dialyzer and connected tubing may be removedfrom reuse machine 80 for storage until the next desired use.

At least some of the connectors used in this invention define firstsealing surfaces that seal with one type of connector, and secondsealing surfaces which seal with another type of connector in such amanner that the first sealing surfaces are positioned in exposed mannerwithin the connectors so that antimicrobial solution in the joinedconnectors can be in contact with the first sealing surfaces. This latercondition corresponds with the situation in FIG. 2, so that the firstsealing surfaces can be exposed to the antimicrobial effect of thecleaning agents of reuse machine 80 or any reuse program desired. Thus,when new central assemblies 28, 62 are provided, the first sealingsurfaces are placed back into sealing operation and do so under asepticconditions, having been cleaned and subjected to antimicrobial action.

In illustration of this, FIG. 3 is an enlarged, longitudinal sectionalview of connectors 46, 48 of arterial set 14, showing the connection andthe first sealing surface 92 which is generally circular in crosssection and formed with screw threads 95 on male portion 94 of connector46, in sealing relation with first sealing surface 92a on female portion98 of connector 48.

FIG. 4 shows another design of connector system of the arterial set,namely connectors 24 and 26 in their connected relationship. Threadedmale sleeve 100 of connector 24 is in screw-threaded engagement withfemale sleeve 102 of connector 26, providing a first sealing surface 104on male sleeve 100 and in sealing relation with female sleeve 102 at itsfirst sealing surface 104a. Connector 24 also carries an outer sleeve106 with inner threads, for use in its second connection.

The corresponding connectors of venous set 18 may be of similar design.

Referring to FIG. 5, this shows the situation when central assembly 28is removed from arterial set 14, and connectors 24, 48 are connectedtogether as illustrated in FIG. 2. Sleeve 98 of connector 48, threadedboth inside and out, is capable of receiving outer sleeve 106 ofconnector 24 in threaded relation as shown in FIG. 5. In thisconfiguration, the outer surface 104 of sleeve 100 of connector 24 isinwardly spaced from the inner surface of sleeve 98, 50 that the firstsealing surfaces 92a, 104 of the respective connectors are open andaccessible to the antimicrobial cleaning/storage solution that isprovided in the configuration of FIG. 2 for cleaning of those surfaces92a, 104. The remaining connectors 46, 26 are respectively connected tocentral assemblies 28, 62, which are removed, and do not participate inthe process of this invention any further. Annular, second sealingsurfaces 108, 108a are provided between the inner surface of outersleeve 106' and the outer surface of sleeve 98, as shown.

Thus, upon reuse of arterial set 14, when a new, sterile centralassembly 28 is provided, one can be confident that the new first sealingsurfaces 92a, 104 formed with new connectors 26, 46 will be aseptic.

Referring to FIG. 6, a preferred connector arrangement for theconnectors of FIG. 3 is shown. In this embodiment, the reusable fifthpatient connector 48a, corresponding to connector 48 of FIG. 1, can beseen to comprise a female tapered first sealing area 92a' correspondingin function to the threaded seal area 92a of FIG. 3. Connector 48a maycarry an outer sleeve 110 surrounding most of the taper area andconnected at an annular connection 112 with the structure 114 definingfemale taper surface 92a'. Outer sleeve 110 carries external threads116.

The mating disposable connector 46a corresponds in function to connector46 of FIG. 1, so that the respective two connectors 48a, 46a connect thesecond flexible tube 50 with the central assembly 28 of a blood set inaccordance with this invention as specifically disclosed in FIG. 1. Thedesign of connector 46a varies from connector 46. First sealing surface118 comprises a male tapered sleeve. Outer sleeve 120 carries internalthreads 122. Male taper surface 118 can seal with female luer surface92a' of connector 48a. Outer sleeve 120 has internal threads 122 whichengage threads 116 of connector 48a in locking relation.

Also, FIG. 6 can represent a detailed view of a preferred design formating connectors 68, 70 in FIG. 1.

Also shown is a disposable third connector 26a which is similar infunction and position to third connector 26 of FIG. 1 but with adifferent design. Male tapered sleeve 109 comprises the first sealingsurface 111 mating with first sealing surface 124 of second connector24a, which corresponds in function to connector 24 of FIG. 1. Thus, maletapered connector 26a seals at the respective first sealing surfaces111, 124 at conical taper 124 of connector 24a. Sleeve 113 of thirdconnector 26a carries threads 115 for engaging the threads 127 ofconnector 24a.

Thus it can be seen that four different connectors are used in thismodification of FIG. 1 to permit central assembly 28 to be removed andreplaced.

Then, in accordance with this invention, when it is desired to remove acentral assembly 28 from between the respective first and secondconduits or flexible tubes for the purposes described above, connector48a may be separated and then rejoined with connector 24a as in FIG. 7,to link together the respective first and second tubes 22, 50 of thedevice of FIG. 1.

As stated, connector 24a defines female taper surface 124, used as thefirst sealing surface for initial locking with a male connector 26a ofcentral assembly 28 as in FIG. 1. Now, outer sleeve 126, having internalthreads 127, locks with the external threads 116 of outer sleeve 110. Atthe same time, at least the distal end of outer sleeve 110 of connector48a comprises a female taper surface 128 which engages with male taperedsurface 130, which is defined by projecting member 132 of connector 24a.Thus projecting member 132 defines female taper surface 124 on theinside and a male taper surface 130 on its exterior, the latterincluding the respective second sealing area 130, 128 that provide thesecond seal between connectors 24a, 48a.

In this latter connection, the first luer taper areas 92a' and 124, aswell as adjacent surfaces 129 and 129a, are exposed to fluid flowthrough the connectors and the respective tubes 22, 50 as shown in FIG.7 for cleaning and antibacterial action. Accordingly, upon reuse oftubes 22, 50 by reconnection with another central assembly, theconnectors 24a, 48a can form an aseptic seal in their respective firstsealing areas 92a', 124.

FIG. 8a shows a detailed modification of FIG. 1, in which the first tube22 is terminated by connector 24b, which is shown to be a male luerlock-type connector capable of connecting with connector 26b in a manneranalogous to the previously described connectors 24, 26.

Second tubing 50 connects with fourth connector 48b, which is afemale-type luer lock connector and which connects with connector 46b ina manner similar to the previous connectors 46, 48.

Then, in FIG. 8b, a detail from the situation of FIG. 2 is shown, wherecentral assembly 28 and second and third connectors 26b, 46b have beenremoved, with connectors 24b, 48b being brought together in connectedbut spaced relationship by an overconnector 136. Each of connectors 24b,48b respectively carry an integral locking ring 132 and sleeve 134.Connector 48b may be of the conventional design for a female luerconnector but with this added, integral outer sleeve 134. Locking ring132 has internal threads 132a, while sleeve 134 may be without threads.

It should be noted that the respective connectors 24b, 48b can engageeach other in conventional luer lock relation. However, in theconfiguration shown in FIG. 8b they do not. Rather, overconnector 136 isprovided, being of generally tubular form, to enclose and to retain therespective locking rings 132, 134 of the connectors in sealed, spacedrelation as shown. Overconnector 136 may be made of a somewhat resilientmaterial so that the respective connectors 24b, 48b may be eachconnected to it in snap-fit relation. Also, overconnector 136 defines aninner, annular spacing member 142 to provide inner spacing forconnectors 24b, 48b by engagement of the sleeves 132, 134 with member142.

The respective second seal area of connector 24b may comprise the outersurface 133 of sleeve 132, while the second seal of connector 48bcomprises the outer surface 135 of sleeve 134. It can be seen that thefirst seal area for connector 24b is the conventional male luer tapersurface 144, while the first sealing surface for connector 48b is thefemale luer taper surface 146.

One advantage of this system lies in the fact that only three differenttypes of connectors need to be provided. Connector 26b can be seen to beof identical design to connector 48b, while connector 46b may beidentical in design to connector 24b. This simplifies both the moldingcost and the manufacture of the system, since the number of designs isreduced.

The third connector, which is overconnector 36, is shown in FIG. 8c inits longitudinal cross section. Overconnector 136 may have optional endretaining members 138, 140, performing as snap-fit detents, which may becontinuously annular or interrupted projections as desired, forretention of the respective connectors pressing inwardly against innerannular spacing member 142. Overconnector 136 may also be of differingend diameters as shown to accommodate the differently sized sleeves 132,134. Also, overconnector 136 may carry integral sealing rings 143, 143ato press against the respective outer surfaces 133, 135 of sleeves 132,134 to provide the desired second seal in the second sealing area.

Thus a sealed connection can be provided between the respectiveconnectors 24b, 48b, by the use of overconnector 136, so that a sealedconnection is provided without the use of the respective luer tapersurfaces 144, 146 of the respective connectors. Rather, these surfaces144, 146 are exposed to the flow of fluid through the respectiveflexible tubes 22, 50 so that these first sealing areas 144, 146 can becleaned and exposed to antimicrobial activity. Thus they may be reusedin an aseptic seal with a new central assembly 28.

Referring to FIG. 8d, a perspective view of another overconnector 136ais shown. While it is shown to be tubular in nature, it may be molded ofa single shot of plastic having a plastic living hinge 150 so that itforms two pivotable semicylindrical halves 152, 154 connected togetherby a conventional clasp 155. Retaining, annular endwalls 154 may beprovided at each end, plus a central, inner ring 157 or the like tospace the connectors in the overconnector. Thus, overconnector 136 maybe applied laterally to the respective connectors 24b, 48b and snappedtogether to form the desired sealed connection for the processing phaseof the set prior to reuse, per FIG. 2.

Alternatively, overconnector 136 may simply comprise an interference fittube, optionally with inner, annular sealing member 142, to providesecond seal areas 141, 143. Such a tube may be elastomeric, for examplesilicone or thermoplastic elastomer.

Referring to FIG. 9, another embodiment for the connectors shown in theconnections of FIG. 2 is shown.

Connectors 24c, 48c may be used as replacements for connectors 24, 48,and also connectors 58, 70 as shown in FIG. 2. These connectors havebeen previously connected as correspondingly shown in FIG. 1 with otherconnectors which may be disposable. Now, the respective first and secondtubes 22, 50 are brought together as in FIG. 2 for the purposesdescribed above.

In this embodiment, connector 24c defines an aperture having a first,outer bore 200 of a diameter which is greater than inner bore 202 of theaperture shown. A first O-ring 204 is provided in the inner bore portion202, while a second O-ring 206 is provided to the outer bore portion200.

Connector 48c defines a lumen 207 extending through it, and a tubularprojection having an inner portion 208 of a diameter that is greaterthan the diameter of an outer projection portion 210. Outer projectionportion 210 carries another O-ring 212.

Alternatively, O-ring 206 may be carried on the first projection portion208 rather than the inner surface of bore portion 200. The technologyused with respect to the specific O-rings with respect to theirsecurance and the materials of which they are formed may beconventional.

Thus, while connectors 24c and 48c may replace connectors 24, 48 (andconnectors 58, 70) in the embodiment of FIG. 2, they are also capable ofconnecting with other connectors as indicated in the embodiment of FIG.1 so that the desired central assembly may be placed between therespective connectors. The connectors of the central assembly may beproportioned to form a seal with the respective O-rings 204, 212, sothat these seals define the respective first sealing areas (aspreviously discussed) for the connectors 24c, 48c. Then, when thecentral assembly is to be disconnected and removed, the respectiveconnectors 24c, 48c may be brought together as shown in FIG. 9, withO-ring 206 comprising the second seal area (discussed previously) whilethe respective first O-rings 204, 212 are exposed as is desired for thefirst seal areas to contact with antiseptic solution passing throughconduits 22, 50, to permit their restoration back into aseptic conditionfor reuse, along with tubes 22, 50.

Referring to FIG. 10, sixth connector 53 is shown in its connectedrelation with reuse port connector 82 which, in turn, is connected tothe reuse apparatus 80 as shown in FIG. 2. The connection of sixthconnector 76 with reuse port connector 84 may be of similar design.

After the extracorporeal circuit comprising tubes 50, 22, 56 and 72 anddialyzer 10 have been essentially cleared of blood, the centralassemblies 28, 62 removed, and the respective tubes interconnected aspreviously discussed, the remaining set portion is connected to thereuse apparatus 80 for cleaning and preparation for storage, prior toreuse.

Reuse port 82 has a first annular sealing surface 81 and an annular stop83.

Connector 53 defines a conventional first annular sealing surface 77comprising a male taper, for use in its connection with a fistula needleset or the like while blood is being circulated through the system.

Connector 53 also carries a conventional sleeve 78 having lockingthreads 78a. The outer annular surface 79 of sleeve 78 may then serve asthe second sealing surface in accordance with this invention, engagingwith the annular sealing surface 81 of reuse port 82, for sealingengagement while in the configuration of FIGS. 2 and 10. Thus, ascleaning/disinfecting fluid passes from reuse device 80 through reuseconnector 82 and sixth connector 53, the male taper first sealing area77 may also be cleaned and disinfected prior to storage and reuse of theset.

Reuse port 82 may be somewhat flexible and resilient so that connector53 can snap-fit into and out of recess 81a defined by connector 82 atthe sealing surface area 81.

Referring to FIG. 11, a different embodiment of the blood conduits of adialysis system in accordance with this invention is disclosed. Asbefore, dialyzer 10 may be identical to the dialyzer of FIG. 1. Thefirst tubing 22 of the arterial set may connect through first connector20 to blood inlet 12 of the dialyzer. First tubing 22 may be identicalto the tubing of FIG. 1, connecting by connector 24 to a differentcentral assembly.

Specifically, central assembly 160 serves the function of both of thecentral assemblies of FIG. 1, with respective first and second lines 22,50, 56, and 72 being connected thereto, the latter four blood linesbeing identical if desired to those of FIG. 1.

Connector 161 connects to roller pump tubing 32a of central assembly160, with a branching heparin line 38a being provided if desired. Rollerpump 32a connects to double chamber unit 162, typically made of a blowmolded plastic parison, and being made of a substantially stiff plasticalthough more resilient material may be used if desired.

The blood from pump segment 32a passes into chamber 164. A branchconnector line 166 is defined by structure 162 to connect to a salineline 168. A top port 167 permits connection to a transducer line 169. Anoutlet port 170 communicates with tubing 172 that carries an injectionsite 174 and outlet connector 176, which may correspond in structure andfunction to connector 46 of FIG. 1. Connector 176 may connect with fifthconnector 48 of second flexible tubing 50, which may be identical to thecorresponding second tube of FIG. 1. Second flexible tube 50 terminatesin a sixth patient connector 52, shown to be connected to a fistulaneedle and tube 178 of conventional design. Thus the arterial set isshown.

Turning now to the venous side, blood outlet 16 of dialyzer 10 isconnected to connector 52 of the first venous tubular portion 22,identical if desired with the corresponding structure of FIG. 1. Firsttube 56 terminates in second connector 58 as before, and communicateswith third venous connector 180 of the structure, communicating withconduit 182 that leads to second chamber 184. Chamber 184 also hasbranch ports providing communication with the chamber for transducerprotector line 186 and another line 188.

Chamber 184 has a bottom exit through filter 190 which may be integrallyattached and of a design similar to that shown in U.S. Pat. No.5,328,461. Bottom exit port communicates with tubing 192 which carriesan injection site and fourth connector 196, which may be similar instructure and function to connector 68 of FIG. 1.

Connector 70 is carried by second venous tube 72, which may be identicalto tube 72 of FIG. 1. Second venous tube 72 is terminated by a sixthconnector 76, shown to be in communication with another fistula needleand tube 198.

Thus, this system may function in the manner similar to the arrangementof FIG. 1, using any of the connector designs shown herein and others aswell, to provide dialysis to a patient, the blood access being throughfistula sets 178, 198. At the termination of dialysis, as in theprevious embodiment, connectors 24, 48 may be separated and connected toeach other, while connectors 58, 70 may be similarly separated andconnected to each other, so that the multiple chamber central assembly162 is removed, and the system assumes the configuration of FIG. 2 forwashing, sterilization, and storage until reuse is again desired of thedialyzer and tubing.

The above has been offered for illustrative purposes only, and is notintended to limit the scope of the invention of this application, whichis as defined in the claims below.

That which is claimed:
 1. The blood treatment method whichcomprises:flowing blood sequentially through connected memberscomprising; a first conduit, a first blood handling member comprising atleast one of a first debubbling chamber, a branching conduit connector,and a pump device fitment; a second conduit; a blood treatment device; athird conduit; a second blood handling member comprising at least one ofa second debubbling chamber, a branching conduit connector, and a pumpdevice fitment; and a fourth conduit; terminating and substantiallyremoving said flowing blood; disconnecting and removing said first andsecond blood handling members; connecting ends of said first and secondconduits and said third and fourth conduits; connecting at least one ofsaid first and fourth conduits to a source of cleaning/storage solution;and flowing said cleaning/storage solution through said first throughfourth conduits and said blood treatment device.
 2. The method of claim1 in which said blood treatment device is a hemodialyzer, and said firstand fourth conduits are thereafter connected together at ends remotefrom said second and third conduits to form a flow loop; circulatingsaid cleaning/storage solution around said flow loop; and dialyzing orrinsing the solution in said flow loop.
 3. The method of claim 1 inwhich said first, second, third and fourth conduits have ends which aretreated with an antimicrobial agent prior to connecting said ends of thefirst and second, and the third and fourth, conduits.
 4. The method ofclaim 1 in which said method is repeated a plurality of times with atleast some of the same first through fourth conduits.
 5. The method ofclaim 1 in which said cleaning solution is circulated through saidfirst, second, third, and fourth conduits and said connected bloodtreatment device.
 6. The method of claim 1 in which, thereafter, newfirst and second blood handling members are respectively connectedbetween the first and second and the third and fourth conduits, andpriming solution is passed through said connected conduits, bloodhandling members, and blood treatment device, followed by flowing bloodsequentially therethrough.
 7. The method of claim 1 in which said firstand fourth conduits have free ends which are connected to reuseequipment for passing cleaning and storage solution through the deviceand connected conduits during the step of flowing said cleaning/storagesolution through said first through fourth conduits.
 8. The bloodtreatment method of claim 1 in which said first through said fourthconduits are free of debubbling chambers, lateral branching connections,and pump device fitments.
 9. The blood treatment method whichcomprises:flowing blood sequentially through connected memberscomprising; a first conduit; a first blood handling member comprising atleast one of a first debubbling chamber, a branching conduit connector,and a pump device fitment; a second conduit; a blood treatment device; athird conduit; a second blood handling member comprising at least one ofa second debubbling chamber, a branching conduit connector, and a pumpdevice fitment; and a fourth conduit; terminating and substantiallyremoving said flowing blood; disconnecting and removing said first andsecond blood handling members; connecting ends of said first and secondconduits and said third and fourth conduits; connecting at least one ofsaid first and fourth conduits to a source of cleaning/storage solution;and passing said cleaning/storage solution through said first throughfourth conduits and said connected blood treatment device, said methodbeing repeated a plurality of times with at least some of the same firstthrough fourth conduits.
 10. The method of claim 9 in which, thereafter,new first and second blood handling members are respectively connectedbetween the first and second and the third and fourth conduits, andpriming solution is passed through said connected conduits, bloodhandling members, and blood treatment device, followed by flowing bloodsequentially therethrough.
 11. The method of claim 10 in which said endsof said first, second, third and fourth conduits are treated with anantimicrobial agent prior to connecting said ends of the first andsecond, and the third and fourth, conduits.
 12. The method of claim 11,in which said blood treatment device is a hemodialyzer.
 13. The bloodtreatment method of claim 9 in which said first through said fourthconduits are free of debubbling chambers, lateral branching connections,and pump device fitments.
 14. The blood treatment method whichcomprises:flowing blood through a blood treatment device and a connectedtubular blood flow set which comprises at least a pair of separableblood flow conduit portions, said tubular set being connected to saidblood treatment device; terminating and substantially removing flowingblood from said blood treatment device and tubular set; disconnectingand removing one of the separable conduit portions of said tubular bloodset from the other said conduit portion; connecting the remainingconduit portion of said tubular set to a source of cleaning/storagesolution while retaining the connection of said remaining blood setconduit portion with said blood treatment device; and flowing saidcleaning/storage solution through said blood treatment device andremaining connected tubular set conduit portion.
 15. The method of claim14 in which said method is repeated a plurality of times with the sameblood treatment device and the remaining conduit portion.
 16. The methodof claim 15 in which said cleaning solution is circulated in a closedloop flow through said remaining tubular set conduit portion and saidconnected blood treatment device.
 17. The method of claim 14 in which,thereafter, a new portion of said tubular blood flow set correspondingin structure and function to the portion of the tubular set previouslyremoved is connected to the remaining blood set portion, and primingsolution is passed through said tubular blood flow set and bloodtreatment device, followed by flowing blood therethrough.
 18. The bloodtreatment method which comprises:flowing blood sequentially throughconnected members comprising: a first conduit, a blood handling membercomprising at least one of a first debubbling chamber, a branchingconduit connector, and a pump device fitment, a second conduit, and ablood treatment device; terminating flow and substantially removing saidflowing blood; disconnecting and removing said blood handling member;connecting ends of said first and second conduits; connecting said firstconduit to a source of cleaning/storage solution; and flowing saidcleaning/storage solution through said first and second conduit and saidblood treatment device.
 19. The method of claim 18 in which said methodis repeated a plurality of time, and, thereafter, a new blood handlingmember is connected between the first and second conduits, and primingsolution is passed through said connected conduits, blood handlingmember, and blood treatment device, followed by flowing bloodsequentially therethrough.
 20. The method of claim 19 in which ends ofsaid first and second conduits are treated with an antimicrobial agentprior to connecting said ends of the first and second conduits.
 21. Themethod of claim 20 in which said blood treatment device is ahemodialyzer.